Fat Atrophy
Conditions
Brief summary
The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.
Detailed description
Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.
Interventions
DEVICE1060nm Diode laser
All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* able to read, understand and voluntarily provide written informed consent * healthy male or female \> 18 years of age seeking treatment for unwanted fat in the abdomen * BMI score is less then 30 * agree to not making any major changes in their diet or lifestyle during the course of the study * able and willing to comply with the treatment / follow up schedule and requirements * women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline
Exclusion criteria
* pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months * any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months * history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study * History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding * Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment * Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions * Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate) * Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder * Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections * Tattoos in the treatment area * Poor quality skin (laxity) * Abdominal wall, muscular abnormality or hernia on physical examination * Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months) * Participation in another clinical study involving the same anatomical areas within the last 6 months * History of keloid and hypertrophic scar formation or poor wound healing in the treatment area * As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment | Week 12 | Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment | Week 12 | Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline |
| Subject Satisfaction | Week 12 | Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied |
| Treatment Pain | Day 1 | Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Treated All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks
Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | All Subjects Treated |
|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 13 |
| Fitzpatrick Skin Type I | 0 Participants |
| Fitzpatrick Skin Type II | 15 Participants |
| Fitzpatrick Skin Type III | 8 Participants |
| Fitzpatrick Skin Type IV | 4 Participants |
| Fitzpatrick Skin Type V | 1 Participants |
| Fitzpatrick Skin Type VI | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment
Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment | -6.9 percentage of body fat | Standard Error 1.4 |
Secondary
Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment
Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment | -0.87 centimeters | Standard Error 0.55 |
Secondary
Subject Satisfaction
Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Subject Satisfaction | 3.3 units on a scale | Standard Deviation 0.9 |
Secondary
Treatment Pain
Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Treatment Pain | 3.1 score on a scale | Standard Deviation 2 |